Clinical and Molecular Characterization of Axial Psoriatic Arthritis (PsA), A Pilot Study

• Conditions: Psoriatic Arthritis

• Registration Number: NCT05925842
• Lead Sponsor: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Brief Summary

Objectives: To identify a candidate set of biomarkers specific to AxPsA. Overview: Clinical and imaging characterization of PsA patients will be combined with extensive molecular assessment of both liquid and tissue compartments to identify biomarkers which differentiate PsA patients with and without axial involvement

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-25
• Study First Submitted: 2023-05-10
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Study First Posted: 2023-06-29
• Last Update Posted: 2023-06-29
• Primary Completion: 2024-02
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Persons with PsA diagnosed by a consultant Rheumatologist with disease duration of > 3 months but < 10 years with or without IBP.

  • Adults between the ages 18 and 80 years, with joint disease onset after 16 years of age

  • Patients able to understand and complete consent procedures

  • Study participants must have PsA, meet CASPAR criteria, and must have active disease as defined by the treating rheumatologist, including an evaluable psoriatic skin lesion amenable to 6mm punch skin biopsy.

    o Psoriasis should be diagnosed by a consultant rheumatologist or dermatologist.

  • Study participants must have been on consistent therapy for their PsA for the past 90 days

  • Study participants must be naïve to biological treatment and targeted synthetic DMARD treatment (examples: JAK inhibitors, apremilast)

Exclusion Criteria

• • Persons with musculoskeletal (peripheral or axial) symptoms for >10 years

  • Persons with planned major surgery (e.g., joint replacement) within the duration of the collection of data for the study
  • Persons with a history of chemotherapy, radiation therapy or immunotherapy for cancer in the preceding 5 years.
  • Persons with ongoing cancer (not excluding non-melanoma skin, cervical/breast in-situ carcinoma) but those fully recovered from an episode of cancer (in remission for more than 5 years) may be included at the discretion of the patient's treating rheumatologist.
  • Persons with an active severe or serious infection
  • Patients with non-severe infection at the discretion of the Investigator
  • Persons with other concomitant disorders incompatible with study (at discretion of Investigator).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target biomarker identification	18 months	Identify candidate biomarkers able to discriminate between PsA with and without axial involvement

Trial Locations

Locations (2)

University of California San Diego; 🇺🇸 La Jolla, California, United States

Seattle Rheumatology Associates; 🇺🇸 Seattle, Washington, United States